Ventricular-Vascular Coupling in Heart Failure

November 7, 2007 updated by: Brigham and Women's Hospital

Ventricular-Vascular Coupling in Patients With Heart Failure and Preserved Ejection Fraction

This study will test the hypothesis that increases in ventricular-vascular stiffness can be demonstrated by arterial tonometry and echocardiography in subjects with heart failure with preserved ejection fraction (HF-nlEF)(i.e. normal left ventricular function.) We will also track changes in pulsatile hemodynamics over time in subjects hospitalized with HF-nlEF.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The pathophysiologic mechanisms responsible for the development of heart failure in people with preserved ejection fraction (i.e. normal left ventricular function) remain poorly understood. One possible mechanism may be the contribution of increased arterial stiffness to changes in pulsatile hemodynamic load during ventricular systole, implicating abnormal ventricular-vascular interactions throughout the cardiac cycle in the pathogenesis of heart failure with normal ejection fraction.

To investigate changes in ventricular-vascular stiffness in subjects with heart failure and normal left ventricular function, comparisons will be made between 3 distinct sub-populations:

  • subjects with heart failure and normal ejection fraction
  • non-diabetic hypertensive controls
  • normotensive controls

Study Type

Observational

Enrollment (Actual)

53

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham & Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

adults with heart failure and preserved left ventricular function

Description

Inclusion Criteria:

Subjects with heart failure and preserved ejection fraction

  • clinical signs of heart failure
  • serum brain natriuretic peptide (BNP) >100pg/mL
  • NYHA functional class II-IV
  • left ventricular ejection fraction(LVEF) >=50% measured by echocardiography
  • Non-diabetic subjects with hypertension
  • treated or untreated essential hypertension
  • LVEF >=50% measured by echocardiography

Diabetic subjects with hypertension

  • Type 2 diabetes
  • treated or untreated essential hypertension
  • LVEF >=50% measured by echocardiography

Normotensive control subjects

  • normal blood pressure (i.e. < 140/90 mmHg)
  • LVEF >=50% measured by echocardiography

Exclusion Criteria:

Subjects with heart failure and preserved ejection fraction

  • atrial fibrillation
  • symptoms of angina or a myocardial infarction (MI) within 6 months
  • known significant coronary artery disease (CAD) (stenosis > 70%)
  • significant valvular heart disease
  • restrictive/constrictive heart disease
  • inability to lie flat for procedure (estimated duration 1 hour)

Non-diabetic subjects with hypertension

  • atrial fibrillation
  • symptoms of angina or a myocardial infarction (MI) within 6 months
  • known significant coronary artery disease (CAD) (stenosis > 70%)
  • significant valvular heart disease
  • restrictive/constrictive heart disease
  • inability to lie flat for procedure (estimated duration 1 hour)
  • prior history of heart failure or unexplained dyspnea

Diabetic subjects with hypertension

  • atrial fibrillation
  • symptoms of angina or a myocardial infarction (MI) within 6 months
  • known significant coronary artery disease (CAD) (stenosis > 70%)
  • significant valvular heart disease
  • restrictive/constrictive heart disease
  • inability to lie flat for procedure (estimated duration 1 hour)
  • prior history of heart failure or unexplained dyspnea

Normotensive control subjects

  • prior history of structural heart disease or ventricular hypertrophy
  • treatment with HMG-Co(A)reductase inhibitors (statins)
  • anti-hypertensive medications
  • cigarette smoking
  • cocaine use
  • excessive alcohol intake

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
3
subjects with heart failure and normal ejection fraction non-diabetic hypertensive controls hypertensive diabetic controls normotensive controls
Procedure: arterial tonometry
used to determine peripheral arterial vascular tone by measuring blood pressure waveforms via a probe attached to the finger.
Other Names:
  • PAT
Procedure: echocardiography
ultrasound test using sound waves to create a moving picture of the heart
Other Names:
  • cardiac echo

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Investigators

  • Principal Investigator: Mark Creager, M.D., Brigham and Women's Hospital
  • Study Director: Akshay S. Desai, M.D., Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

November 9, 2007

Last Update Submitted That Met QC Criteria

November 7, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2003P-001769

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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